Phase III Trial of High Dose vs. Standard Dose Vit D2 With Docetaxel in Met Breast ca

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-07-31

Brief Summary

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Randomized phase III trial to determine the effectiveness of High dose versus Standard dose of Vitamin D2 (Ergocalciferol) given with Docetaxel in patients with metastatic breast cancer

Detailed Description

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2 Arms Randomization in patients with metastatic breast cancer.

Arm A = Docetaxel + High dose Vitamin D2

Arm B = Docetaxel + Standard dose Vitamin D2

Conditions

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Breast Cancer

Keywords

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Vitamin D in patients with metastatic breast cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Arm A

Arm A = Docetaxel + High dose Vitamin D2

Group Type EXPERIMENTAL

Docetaxel + High dose Vitamin D2

Intervention Type DRUG

Docetaxel + High dose Vitamin D2

Arm B

Docetaxel + Standard dose Vitamin D2

Group Type ACTIVE_COMPARATOR

Docetaxel + Standard dose Vitamin D2

Intervention Type DRUG

Docetaxel + Standard dose Vitamin D2

Interventions

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Docetaxel + High dose Vitamin D2

Intervention Type DRUG

Docetaxel + Standard dose Vitamin D2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically proven metastatic adenocarcinoma of the breast.
* Gender: female.
* Age ≥18 years.
* ECOG performance status ≤ 2.(see appendix I)
* 25 (OH) Vitamin D level ≤ 100nmol/L (40ng/L).
* No more than 1 prior chemotherapy regimen not including Docetaxel or Paclitaxel for metastatic breast cancer.
* Patients progressed on Doxorubicin or epirubicin as first line for metastatic breast cancer is eligible.
* Concurrent bisphosphonate therapy allowed.
* Life expectancy more than 6 months
* At least 12 months since prior adjuvant or neo-adjuvant chemotherapy including Taxanes regimens.
* Adequate hematologic, hepatic and renal function.
* Written informed consent.

Exclusion Criteria

* Pregnant or lactating women.
* Male breast cancer.
* Women of childbearing potential unless surgically sterile or using adequate measures of contraception.
* Metastatic inflammatory breast cancer.
* CNS metastasis.
* Leptomeningeal carcinomatosis.
* Malignant hypercalcemia.
* History of kidney stones.
* History of active primary hyperparathyroidism.
* Normal 25 (OH) Vitamin D level ≥100 nmol/L or ≥ 40 ng/L.
* Previous or concomitant malignancy of any type, except adequately treated basal cell carcinoma of the skin or in situ cervix cancer.
* Patient on any anti-Psychotic medications or Steroid therapy.
* History of malabsorption syndrome (pancreatic insufficiency, celiac disease and tropical sprue).
* Any of the following abnormal baseline hematological values:

* ANC \< 1.0 x109/L, or platelets \< 100.000 x 109/L.
* Any of the following abnormal laboratory tests: total serum bilirubin \>2.00 x ULN (upper limit of normal), AST, ALT \> 2.5 x ULN or ALP \>2.50 x ULN (upper limit of normal).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Taher Al-Tweigeri, MD

Role: PRINCIPAL_INVESTIGATOR

KFSHRC

Dahish Ajarim, MD

Role: STUDY_DIRECTOR

KFSHRC

Locations

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